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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05794906




Registration number
NCT05794906
Ethics application status
Date submitted
21/03/2023
Date registered
3/04/2023
Date last updated
3/06/2024

Titles & IDs
Public title
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
Secondary ID [1] 0 0
2022-501343-33-00
Secondary ID [2] 0 0
21492
Universal Trial Number (UTN)
Trial acronym
ARASTEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biochemically Recurrent Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darolutamide (BAY1841788, Nubeqa)
Other interventions - Placebo matching darolutamide
Other interventions - ADT

Experimental: Darolutamide+ADT - Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.

Placebo Comparator: Placebo+ADT - Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.


Treatment: Drugs: Darolutamide (BAY1841788, Nubeqa)
Coated tablet, 300 mg / tablet, oral.

Other interventions: Placebo matching darolutamide
Coated tablet, oral

Other interventions: ADT
Luteinizing hormone-releasing hormone [LHRH] agonist/antagonists
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
Timepoint [1] 0 0
After randomization to after last treatment, approximately 24 months
Secondary outcome [1] 0 0
Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
Timepoint [1] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [2] 0 0
Time to Castration-resistant prostate cancer (CRPC) assessed by investigator
Timepoint [2] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [3] 0 0
Time to initiation of first subsequent systemic antineoplastic therapy
Timepoint [3] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [4] 0 0
Time to loco-regional progression by PSMA PET/CT
Timepoint [4] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [5] 0 0
Time to first Symptomatic skeletal event (SSE)
Timepoint [5] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [7] 0 0
Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)
Timepoint [7] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [8] 0 0
Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
Timepoint [8] 0 0
After randomization to after last treatment, approximately 24 months
Secondary outcome [9] 0 0
Time to symptomatic progression
Timepoint [9] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [10] 0 0
Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity
Timepoint [10] 0 0
After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
Secondary outcome [11] 0 0
Number of participants who discontinue study treatment due to a TEAE
Timepoint [11] 0 0
After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months

Eligibility
Key inclusion criteria
- Capable of giving signed informed consent as described which includes compliance with
the requirements, restrictions listed in the informed consent form (ICF), and in this
protocol.

- Male =18 years of age at the time of signing the informed consent.

- Histologically or cytologically confirmed adenocarcinoma of prostate.

- Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant
radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit
(or refused) for ART or SRT, or primary radiotherapy (RT).

- High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling
time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA
=0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART
or SRT (local or central values accepted), or PSA =2 ng/mL above the nadir after
primary RT only (local or central values accepted).

- Participants must undergo prostate-specific membrane antigen positron emission
tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using
either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by
blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion
of prostate cancer.

- Serum testosterone =150 ng/dL (5.2 nmol/L) (local or central values accepted).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Blood counts at screening: Hemoglobin =9.0 g/dL (participant must not have received
blood transfusion within 7 days prior to sample being taken); Absolute neutrophil
count (ANC) =1.5x10^9/L (participant must not have received any growth factor within 4
weeks prior to sample being taken); Platelet count =100x10^9/L.

- Screening values of: Alanine aminotransferase (ALT) =1.5 x upper limit of normal
(ULN); Aspartate aminotransferase (AST) =1.5 x ULN; Total bilirubin (TBL) =1.5 ULN,
(except participants with a diagnosis of Gilbert's disease); Estimated glomerular
filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula.

- Sexually active male participants must agree to use contraception as detailed in the
protocol during the Treatment period and for at least 1 week after the last dose of
study treatment, and refrain from donating sperm during this period.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Pathological finding consistent with small cell, ductal or =50 % component of
neuroendocrine carcinoma of the prostate.

- History of bilateral orchiectomy.

- Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles,
lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR
during screening.

- Brain metastasis on PSMA PET /CT by BICR at screening.

- High-risk BCR after primary radiotherapy with new loco-regional lesions on screening
PSMA PET/CT who are eligible for curative salvage prostatectomy.

Note: Participants treated with curative salvage prostatectomy after primary RT who meet
the PSA criteria (inclusion criteria 5) may be considered for the study.

- Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen
receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months
prior to signing of the ICF.

- Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.

- Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or
salvage treatment completed within 8 weeks prior to signing of the ICF.

- Any prior malignancy (other than adequately treated basal cell or squamous cell skin
cancer, superficial bladder cancer, or any other cancer in situ currently in complete
remission) within 5 years.

- History of pelvic radiotherapy for other malignancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2029
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktownn
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department - Liverpool
Recruitment hospital [4] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [5] 0 0
GenesisCare Newcastle - Newcastle
Recruitment hospital [6] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [7] 0 0
St Vincents Hospital Sydney - Sydney
Recruitment hospital [8] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment hospital [10] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [11] 0 0
Bundaberg Hospital, Genesis Cancer Care - Bundaberg - Bundaberg
Recruitment hospital [12] 0 0
Wide Bay Hospital and Health Service - Hervey Bay Hospital - Pialba
Recruitment hospital [13] 0 0
Tasman Health Care - Southport
Recruitment hospital [14] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [15] 0 0
Eastern Clinical Research Unit - Box Hill - Box Hill
Recruitment hospital [16] 0 0
Epworth HealthCare - East Melbourne
Recruitment hospital [17] 0 0
Cabrini Medical Centre - Malvern
Recruitment hospital [18] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [19] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [20] 0 0
Northern Hospital - Epping
Recruitment hospital [21] 0 0
Barwon Health - Geelong
Recruitment hospital [22] 0 0
Austin Health - Heidelberg
Recruitment hospital [23] 0 0
Western Urology - Maribyrnong
Recruitment hospital [24] 0 0
Prince of Wales Hospital NSW - Randwick
Recruitment postcode(s) [1] 0 0
2148 - Blacktownn
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2109 - Macquarie University
Recruitment postcode(s) [5] 0 0
2290 - Newcastle
Recruitment postcode(s) [6] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [7] 0 0
2010 - Sydney
Recruitment postcode(s) [8] 0 0
2076 - Wahroonga
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment postcode(s) [10] 0 0
4029 - Brisbane
Recruitment postcode(s) [11] 0 0
4670 - Bundaberg
Recruitment postcode(s) [12] 0 0
4655 - Pialba
Recruitment postcode(s) [13] 0 0
4215 - Southport
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
Recruitment postcode(s) [15] 0 0
3128 - Box Hill
Recruitment postcode(s) [16] 0 0
3002 - East Melbourne
Recruitment postcode(s) [17] 0 0
3144 - Malvern
Recruitment postcode(s) [18] 0 0
3052 - Melbourne
Recruitment postcode(s) [19] 0 0
6009 - Nedlands
Recruitment postcode(s) [20] 0 0
3076 - Epping
Recruitment postcode(s) [21] 0 0
3220 - Geelong
Recruitment postcode(s) [22] 0 0
- Heidelberg
Recruitment postcode(s) [23] 0 0
3032 - Maribyrnong
Recruitment postcode(s) [24] 0 0
2031 - Randwick
Recruitment outside Australia
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Illinois
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Country [163] 0 0
United Kingdom
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London

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Commercial sector/Industry
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Bayer
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Summary
Brief summary
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence
(BCR) of prostate cancer.

BCR means that in men who had prostate cancer and were treated by either surgery and/ or
radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of
prostate cancer cells activity. The PSA increase means that the cancer has come back even
though conventional imaging such as computed tomography (CT) scans, magnetic resonance
imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more
sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission
tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not
detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading
to other parts of the body, particularly when PSA levels raised to a certain limit within a
short period of time after local therapies. Once the cancer spreads to other parts of the
body, it can become even harder to treat.

In men with prostate cancer, male sex hormones (also called androgens) like testosterone can
help the cancer grow and spread. To reduce androgens levels in these patients, there are
treatments that block androgens production in the body called androgen deprivation therapy
(ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth
and spread is to block the action of androgen receptors on prostate cancer cells called
androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block
the action of androgens receptors and are available for the treatment of prostate cancer in
addition to ADT. It is already known that men with prostate cancer benefit from these
treatments.

The main objective of this study is to learn if the combination of darolutamide and ADT
prolongs the time that the participants live without their cancer getting worse, or to death
due to any cause, compared to placebo (which is a treatment that looks like a medicine but
does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.

To do this, the study team will measure the time from the date of treatment allocation to the
finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any
cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer"
that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein
often found in large amounts on prostate cancer cells.

To avoid bias in treatment, the study participants will be randomly (by chance) allocated to
one of two treatment groups. Based on the allocated treatment group, the participants will
either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The
study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The
treatment duration is pre-specified to be 24 months unless the cancer gets worse, the
participants have medical problems, or they leave the study for any reason. In addition,
image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the
benefits and risks of this type of therapy.

During the study, the study team will:

- take blood and urine samples.

- measure PSA and testosterone levels in the blood samples

- do physical examinations

- check the participants' overall health

- examine heart health using electrocardiogram (ECG)

- check vital signs

- check cancer status using PSMA PET/CT scans, CT, MRI and bone scans

- take tumor samples (if required)

- ask the participants if they have medical problems

About 30 days after the participants have taken their last treatment, the study doctors and
their team will check the participants' health and if their cancer worsened. The study team
will continue to check this and regularly ask the participants questions about medical
problems and subsequent therapies until they leave the study for any reason or until they
leave the study for any reason or until the end of the study, whatever comes first.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05794906
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Bayer Clinical Trials Contact
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(+)1-888-84 22937
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clinical-trials-contact@bayer.com
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05794906